Clinical Trial: Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.
Brief Summary: The objective is to demonstrate equivalence of three IC51 batches in terms of Geometric Mean Titers for anti-JEV neutralizing antibody.
Detailed Summary:
This is a randomized, controlled, multi‐center, double blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years.
624 subjects will be enrolled at approximately 6 sites in study centers in Austria and Germany.
Sponsor: Valneva Austria GmbH
Current Primary Outcome: GMT for Anti-JEV Neutralizing Antibody [ Time Frame: day 56 ]
Original Primary Outcome: Geometric Mean Titers for anti-JEV neutralizing antibody
Current Secondary Outcome:
- Safety [ Time Frame: study duration ]Safety laboratory parameters, rate of SAEs and medically attended AEs, systemic and local tolerability
- SCR for Anti-JEC Neutralizing Antibody Titer [ Time Frame: day 56 ]
Original Secondary Outcome: Safety and Adverse Events
Information By: Valneva Austria GmbH
Dates:
Date Received: January 4, 2008
Date Started: September 2006
Date Completion:
Last Updated: March 29, 2016
Last Verified: March 2016